# K991383: Hydrocision Debdridement System

- Pathway: 510(k) (Traditional)
- Applicant: Hydrocision, Inc.
- Decided: Mar 31, 2000 after 345 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972069 (1997). 2 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972069: Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips, Rechargeable Battery Pack, Stryker Instruments (1997) Summary page 1.
- K982266: Hydrocision Arthrojet System, Hydrocision, Inc. (1998) Summary page 1.
- (no number) Zimmer Pulsavac Wound Debridement System: named in the summary without a submission number

## Most influential descendants
- K012464: Helix Hydro-Jet (2001), 19 descendants of its own
- K022613: Helix Hydro-Jet (2002), 17 descendants of its own
- K033590: Erbe Helix Hydro-Jet (2004), 16 descendants of its own
- K072404: Erbe Erbejet 2 System (2007), 14 descendants of its own
- K062712: Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 (2007), 14 descendants of its own

## Indications for use
The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

Source page: https://510kreport.com/device/K991383
Methodology: https://510kreport.com/methodology